PMA P090013S107
- Device
- REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S107
- Product code
- LWP
- Decision date
- 2013-09-27
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- REVO MRI IPG
- Applicant
- Medtronic, Inc.
- PMA number
- P090013
- Supplement
- S107
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-09-27
- Decision code
- APPR
- Date received
- 2013-07-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MYCARELINK PATIENT MONITOR MODELS 24950 (SOFTWARE VERSION R50), 24951 (SOFTWARE VERSION R50.A.1), AND 24955 (SOFTWARE VERSION V29) TO BE USED WITH THE DEVICES.